Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Actively Recruiting

Phase 3

All Genders

NCT05561387

Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Led by SWOG Cancer Research Network · Updated on 2025-06-04

510

Participants Needed

397

Research Sites

398 weeks

Total Duration

AI-Summary

What this Trial Is About

This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.

CONDITIONS

Official Title

Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of multiple myeloma confirmed by standard criteria within 28 days before registration
Measurable disease based on specified protein levels in blood or urine within 28 days before registration
Categorized as frail or intermediate-fit using a myeloma frailty index within 28 days before registration
For frail participants: kidney dysfunction allowed except dialysis; hemoglobin >= 7 g/dL; platelets >= 50 x 10^9/L; absolute neutrophil count >= 0.75 x 10^9/L (all labs within 28 days before registration)
For intermediate-fit participants: one or more of the following within 28 days before registration: creatinine clearance <30 ml/min; hemoglobin 7-8 g/dL; platelets 50-75 x10^9/L; absolute neutrophil count 0.75-1 x10^9/L; or Revised International Staging System stage III disease
Complete medical history and physical exam within 28 days before registration
Whole body imaging within 60 days before registration (PET/CT recommended, or low-dose CT, MRI, or skeletal survey if PET/CT not feasible)
Total bilirubin <= 2x institutional upper limit of normal unless Gilbert's disease (then <= 5x)
AST/ALT <= 3x institutional upper limit of normal within 28 days before registration
Adequate cardiac function assessed within 14 days before registration; no class 3 or 4 cardiac status
Controlled diabetes with HbA1c <= 7 within 14 days before registration
HIV infection controlled with undetectable viral load on therapy within 6 months before registration
Chronic hepatitis B infection controlled with undetectable viral load within 28 days before registration
Hepatitis C infection treated and cured or undetectable viral load if on treatment within 28 days before registration
ECOG performance status 0-2 (score 3 allowed if due to multiple myeloma)
Consent to participate in specimen banking and patient-reported outcomes if able to complete questionnaires in English or Spanish
Signed informed consent according to institutional and federal guidelines

You will not qualify if you...

Prior systemic therapy for multiple myeloma, except emergency short course corticosteroids, one cycle of non-daratumumab regimen, or localized palliative radiation completed at least 3 days before study treatment
Grade 4 peripheral neuropathy before registration
Uncontrolled blood pressure (SBP > 140 mmHg or DBP > 90 mmHg) within 14 days before registration
Prior or concurrent malignancy that may interfere with safety or efficacy assessment
Pregnancy or nursing; must agree to effective contraception if of reproductive potential

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Trial Site Locations

Total: 397 locations

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States, 98508

Actively Recruiting

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States, 99504

Actively Recruiting

Alaska Breast Care and Surgery LLC